Status:
COMPLETED
Congenital Heart Disease Physical Activity Lifestyle Study
Lead Sponsor:
Jamie Jackson
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Disease Other
Physical Activity
Eligibility:
All Genders
15-18 years
Phase:
NA
Brief Summary
This study will adapt a physical activity lifestyle intervention to adolescent and emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels....
Eligibility Criteria
Inclusion
- Between the ages of 15-18 (if 18, must be in high school and/or still living at home)
- Are diagnosed with moderate or complex structural congenital heart disease
- Live within 120 miles of Nationwide Children's Hospital
Exclusion
- Do no speak or write proficiently in English
- Have cognitive impairments that would interfere with the completion of study procedures
- Are diagnosed with a genetic syndrome (e.g., Downs, Marfans)
- Have been engaged in a formal exercise program within the past 6 months
- Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months
- Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity
- Are unable to complete a treadmill-based exercise stress test
- Are currently pregnant
- Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)
- \>60 min/day of moderate-to-vigorous physical activity per the accelerometer
- Do not have internet access or a device for videoconferencing with a PA coach
Key Trial Info
Start Date :
November 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03335475
Start Date
November 7 2017
End Date
April 7 2021
Last Update
May 3 2023
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205